Renal InsufficiencyPhase 1NCT03189498
A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-64041575 in Adult Participants With Various Degrees of Renal Function
A Phase 1 study testing JNJ-64041575 in people with Renal Insufficiency, run by Janssen Pharmaceutica N.V., Belgium at 2 sites in Germany.
Trial summary
The primary purpose of this study is to evaluate the pharmacokinetic (PK) and systemic exposure of JNJ-63549109 and JNJ-64167896 after a single oral dose of JNJ-64041575 in adult participants with various degrees of renal function (mildly, moderately, or severely impaired, or end-stage renal disease [ESRD] with or… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- JNJ-64041575
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesGermany
- Study dates
- 11 Jul 2017to 6 Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must have a body mass index (BMI: body weight in kilogram (kg) divided by the square of height in meters) of 18.0 to 36.0 kilogram per meter square (kg/m^2), extremes included, and a body weight not less than 50.0 kg, inclusive, at screening
- Contraceptive use by female participants, male participants and their female partners should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies if these are stricter than what is proposed in these inclusion criteria in the protocol
- Participants with normal renal function (Group 1):
- -Participant must have an estimated glomerular filtration rate (eGFR) >= 90 milliliter per minute (mL/min)
- Participants with renal impairment (Groups 2 to 4):
- The following classifications of renal function are used: Mild renal impairment (eGFR greater than or equal to [>=] 60 to less than [<] 90 mL/min), Moderate renal impairment (eGFR >= 30 to <60 mL/min), Severe renal impairment (eGFR >=15 to <30 mL/min)
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- Participants with end-stage renal disease (ESRD) with or without hemodialysis (Group 5):
- Participant must have an eGFR <15 mL/min if not on hemodialysis
- Participant on hemodialysis treatment must have been on the same hemodialysis regimen for at least 3 months before screening
Who cannot join
- All participants (Groups 1 to 5):
- Participant has any surgical or medical condition that potentially may alter the absorption, metabolism, or excretion of the study drug (example, Crohn's disease), with the exception of renal impairment
- Participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participant with a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs
- Participant has known allergies, hypersensitivity, or intolerance to JNJ-64041575 or its excipients
- Participants with evidence of an active infection
- Participant is a woman who is pregnant or breastfeeding
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
CRS Clinical Research Services Kiel
Kiel
APEX GmbH
München, 81241
About this study
Official title: A Phase 1, Open-label, Single-dose, Parallel-group Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-64041575 in Adult Subjects With Various Degrees of Renal Function
The primary purpose of this study is to evaluate the pharmacokinetic (PK) and systemic exposure of JNJ-63549109 and JNJ-64167896 after a single oral dose of JNJ-64041575 in adult participants with various degrees of renal function (mildly, moderately, or severely impaired, or end-stage renal disease [ESRD] with or without hemodialysis) compared to adult participants with normal renal function.
- Conditions
- Renal Insufficiency
- Being tested
- JNJ-64041575
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-64041575Drug
Also called ALS-008176, lumicitabine
All participants will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250 mg tablets) on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Participants With Normal Renal Function | Experimental | Adult participants with normal renal function (estimated glomerular filtration rate [eGFR] greater than or equal to [>=] 90 milliliter per minute [mL/min]) will receive a single oral dose of 1,000 milligram (mg) JNJ-64041575 (4*250-mg tablets) on Day 1 of treatment period. Receives: Drug: JNJ-64041575 |
| Group 2: Participants With Mild Renal Impairment | Experimental | Adult participants with mild impaired renal function (eGFR >=60 to less than [<] 90 mL/min) will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250-mg tablets) on Day 1 of treatment period. Receives: Drug: JNJ-64041575 |
| Group 3: Participants With Moderate Renal Impairment | Experimental | Adult participants with moderate impaired renal function (eGFR >=30 to <60 mL/min) will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250-mg tablets) on Day 1 of treatment period. Receives: Drug: JNJ-64041575 |
| Group 4: Participants With Severe Renal Impairment | Experimental | Adult participants with severe impaired renal function (eGFR >= 15 to <30 mL/min) will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250-mg tablets) on Day 1 of treatment period. Receives: Drug: JNJ-64041575 |
| Group 5: Participants With ESRD With or Without Hemodialysis | Experimental | Adult participants with end-stage renal disease (ESRD) (eGFR <15 mL/min if not on hemodialysis or requiring hemodialysis treatment for at least 3 months before screening if on hemodialysis) will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250-mg tablets) on Day 1 of treatment period. Participants with ESRD on hemodialysis will be dosed on an interdialysis day within 24 hours of their last hemodialysis treatment. Receives: Drug: JNJ-64041575 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
The Cmax is the maximum observed plasma concentration.
Measured: Predose, Day 1: 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 336 (Day 15) hours postdose
Area Under the Plasma Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC [0-last])
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to the time of the last measurable concentration.
Measured: Predose, Day 1: 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 336 (Day 15) hours postdose
Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC [0-infinity])
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Measured: Predose, Day 1: 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 336 (Day 15) hours postdose
Secondary outcomes (1)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: Up to 20 to 28 days after study drug intake (approximately 5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start11 Jul 2017
- Primary completion6 Dec 2017
- Study completion6 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutica N.V., Belgium
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutica N.V., Belgium Clinical Trial, Study director, Janssen Pharmaceutica N.V., Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189498
- Sponsor's protocol ID
- CR108333
- Other IDs
- 2017-000875-10, 64041575RSV1006, 2017
- Status last verified
- Jan 2025
- First submitted
- 15 Jun 2017
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single-dose, Parallel-group Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-64041575 in Adult Subjects With Various Degrees of Renal Function
- ClinicalTrials.gov ID
- NCT03189498
- Acronym / sponsor ID
- CR108333
- Conditions
- Renal Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Janssen Pharmaceutica N.V., BelgiumIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 6 Dec 2017 (actual)
- Study completion
- 6 Dec 2017 (actual)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate the pharmacokinetic (PK) and systemic exposure of JNJ-63549109 and JNJ-64167896 after a single oral dose of JNJ-64041575 in adult participants with various degrees of renal function (mildly, moderately, or severely impaired, or end-stage renal disease [ESRD] with or without hemodialysis) compared to adult participants with normal renal function.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1: Participants With Normal Renal Function | Experimental | Drug: JNJ-64041575Adult participants with normal renal function (estimated glomerular filtration rate [eGFR] greater than or equal to [>=] 90 milliliter per minute [mL/min]) will receive a single oral dose of 1,000 milligram (mg) JNJ-64041575 (4*250-mg tablets) on Day 1 of treatment period. |
| Group 2: Participants With Mild Renal Impairment | Experimental | Drug: JNJ-64041575Adult participants with mild impaired renal function (eGFR >=60 to less than [<] 90 mL/min) will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250-mg tablets) on Day 1 of treatment period. |
| Group 3: Participants With Moderate Renal Impairment | Experimental | Drug: JNJ-64041575Adult participants with moderate impaired renal function (eGFR >=30 to <60 mL/min) will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250-mg tablets) on Day 1 of treatment period. |
| Group 4: Participants With Severe Renal Impairment | Experimental | Drug: JNJ-64041575Adult participants with severe impaired renal function (eGFR >= 15 to <30 mL/min) will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250-mg tablets) on Day 1 of treatment period. |
| Group 5: Participants With ESRD With or Without Hemodialysis | Experimental | Drug: JNJ-64041575Adult participants with end-stage renal disease (ESRD) (eGFR <15 mL/min if not on hemodialysis or requiring hemodialysis treatment for at least 3 months before screening if on hemodialysis) will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250-mg tablets) on Day 1 of treatment period. Participants with ESRD on hemodialysis will be dosed on an interdialysis day within 24 hours of their last hemodialysis treatment. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participant must have a body mass index (BMI: body weight in kilogram (kg) divided by the square of height in meters) of 18.0 to 36.0 kilogram per meter square (kg/m^2), extremes included, and a body weight not less than 50.0 kg, inclusive, at screening
- Contraceptive use by female participants, male participants and their female partners should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies if these are stricter than what is proposed in these inclusion criteria in the protocol
- -Participant must have an estimated glomerular filtration rate (eGFR) >= 90 milliliter per minute (mL/min)
- The following classifications of renal function are used: Mild renal impairment (eGFR greater than or equal to [>=] 60 to less than [<] 90 mL/min), Moderate renal impairment (eGFR >= 30 to <60 mL/min), Severe renal impairment (eGFR >=15 to <30 mL/min)
- Participant must have an eGFR <15 mL/min if not on hemodialysis
Key exclusion criteria (7 listed)
- Participant has any surgical or medical condition that potentially may alter the absorption, metabolism, or excretion of the study drug (example, Crohn's disease), with the exception of renal impairment
- Participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participant with a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs
- Participant has known allergies, hypersensitivity, or intolerance to JNJ-64041575 or its excipients
- Participants with evidence of an active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-64041575Also: ALS-008176, lumicitabineAll participants will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250 mg tablets) on Day 1. | Drug | Group 1: Participants With Normal Renal Function, Group 2: Participants With Mild Renal Impairment, Group 3: Participants With Moderate Renal Impairment, Group 4: Participants With Severe Renal Impairment, Group 5: Participants With ESRD With or Without Hemodialysis |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: Predose, Day 1: 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 336 (Day 15) hours postdose
The Cmax is the maximum observed plasma concentration.
Area Under the Plasma Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC [0-last])
Time frame: Predose, Day 1: 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 336 (Day 15) hours postdose
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to the time of the last measurable concentration.
Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC [0-infinity])
Time frame: Predose, Day 1: 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 336 (Day 15) hours postdose
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
1 secondary outcome
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 20 to 28 days after study drug intake (approximately 5 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Pharmaceutica N.V., Belgium Clinical Trial study director
Janssen Pharmaceutica N.V., Belgium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-64041575 in people with Renal Insufficiency, run by Janssen Pharmaceutica N.V., Belgium at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) (time frame: Predose, Day 1: 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 336 (Day 15) hours postdose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.